NCT05452603

Usefulness of Wireless pH Monitoring in GERD Diagnosis

Usefulness of Wireless pH Monitoring in the Diagnosis of Gastroesophageal Reflux Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Hospital de Clinicas José de San Martín · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Gastroesophageal reflux disease (GERD) is extremely common in our environment. Its diagnosis is complex. The Lyon Consensus defined, based on 24-hour pH monitoring, that an acid exposure time greater than 6% is definitely abnormal, less than 4% is normal, and between 4 and 6% is a gray area. The objective of this study is to describe the change in therapeutic behavior based on the result of prolonged pH recording performed with a 96-hour wireless pH measurement capsule in patients with GERD symptoms and an acid exposure time measured by impedanciometry/pH of 24 hours in the gray area. Also, describe the therapeutic outcomes.

Detailed description

Thirty consecutive patients with GERD symptoms and an acid exposure time (AET) measured by impedance measurement/pH between 4 and 6% will be included. A 96-hour off IBP wireless pH monitoring capsule will be performed. The worst day, the average of the 4 days and the presence of 2 or more days with AET\>6% and the 4 days with AET\<4% will be recorded. Patients will be categorized into GERD, reflux hypersensitivity, and functional heartburn. A treatment will be established based on these categories and the GERDq will be measured at 8 weeks of treatment.

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
DEVICE	96-hour off IBP wireless pH monitoring capsule	The endoscopic pH measurement capsule will be placed 6cm above the squamocolumnar junction, determined endoscopically, in the sedated patient. Then the plot will be read.

Timeline

• Start date: 2021-06-20
• Primary completion: 2024-06-20
• Completion: 2024-07-20
• First posted: 2022-07-11
• Last updated: 2024-10-23

Locations

1 site across 1 country: Argentina

Regulatory

• FDA-regulated device study